A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
Summary
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. Study GA39855 (POLYP 2; NCT03280537) was another Phase III study by the Sponsor with identical objectives and design and was run in parallel with this study.
Timeline
- Start
- 2017-11-15
- Primary completion
- 2019-03-11
- Completion
- 2019-03-11
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Omalizumab; p <0.0001; Difference in Least Squares Means -1.14 (95% CI -1.59 to -0.69) NCT03280550 ↗
registry analysis (superiority test); Placebo vs Omalizumab; p = 0.0004; Difference in Least Squares Means -0.55 (95% CI -0.84 to -0.25) NCT03280550 ↗
release “In the phase III POLYP 1 and POLYP 2 studies, omalizumab met both co-primary endpoints” novartis.com ↗
Publications
- Meltzer EO, Mullol J, Ko J, Saenz R, Steinke JW, Millette LA, Gevaert P. Omalizumab improves sleep and health status for patients with chronic rhinosinusitis with nasal polyps: An analysis of randomized clinical trials. Int Forum Allergy Rhinol. 2024 Jul;14(7):1163-1172. doi: 10.1002/alr.23322. Epub 2024 Jan 10.
- Gevaert P, Mullol J, Saenz R, Ko J, Steinke JW, Millette LA, Meltzer EO. Omalizumab improves sinonasal outcomes in patients with chronic rhinosinusitis with nasal polyps regardless of allergic status. Ann Allergy Asthma Immunol. 2024 Mar;132(3):355-362.e1. doi: 10.1016/j.anai.2023.11.001. Epub 2023 Nov 10.
- Braid J, Islam L, Gugiu C, Omachi TA, Doll H. Meaningful changes for efficacy outcomes in patients with chronic rhinosinusitis with nasal polyps. World Allergy Organ J. 2023 May 13;16(5):100776. doi: 10.1016/j.waojou.2023.100776. eCollection 2023 May.
- Damask C, Chen M, Holweg CTJ, Yoo B, Millette LA, Franzese C. Defining the Efficacy of Omalizumab in Nasal Polyposis: A POLYP 1 and POLYP 2 Subgroup Analysis. Am J Rhinol Allergy. 2022 Jan;36(1):135-141. doi: 10.1177/19458924211030486. Epub 2021 Aug 12.
- Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.
- Peters AT, Han JK, Hellings P, Heffler E, Gevaert P, Bachert C, Xu Y, Chuang CC, Neupane B, Msihid J, Mannent LP, Guyot P, Kamat S. Indirect Treatment Comparison of Biologics in Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2021 Jun;9(6):2461-2471.e5. doi: 10.1016/j.jaip.2021.01.031. Epub 2021 Feb 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omalizumab | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Omalizumab | Monoclonal antibody | 600 mg | Subcutaneous |